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PATH is a global nonprofit dedicated to achieving health equity. With more than 40 years of experience forging multisector partnerships and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world's most pressing health challenges.
PATH's Center for Vaccine Innovation and Access (CVIA) brings together our expertise across every stage of the long and complex process of vaccine research, development, and delivery to make lifesaving vaccines widely available to children and communities across the world. CVIA's current portfolio encompasses more than two dozen vaccines either in development or already in use to protect against fifteen different diseases. Our focus is on vaccines to address the leading diseases that claim children's lives worldwide: pneumonia, diarrheal disease, and malaria; as well as other global health priorities, such as polio and meningitis. We work in partnership with national health ministries, pharmaceutical manufacturers, donors, international financing and regulatory organizations, and many others.
PATH is currently seeking a highly skilled and experienced individual to join the team in the crucial role of Deputy Director, Clinical Quality Management. This position will report to the Global Head, Quality Unit, CVIA. The Deputy Director will play a pivotal role in ensuring the integrity, compliance, and quality of PATH clinical studies globally. This senior-level position requires an individual with extensive industry experience, exceptional leadership skills, and a proven track record in developing and implementing fit for purpose quality management systems for clinical practices.
Responsibilities
- Pioneer industry-leading clinical quality assurance techniques and approaches while maintaining compliance and efficiency in related operational processes. Develop strategies to identify and mitigate related risks across good clinical practices (GCP) activities.
- Provide strategic leadership and direction for the Clinical Quality Assurance operations.
- Develop, implement, and continuously improve global GCP quality strategies that align with PATH's goals and objectives, setting the overall vision and long-term priorities for the Clinical Quality Assurance organization.
- Evolve and chair the Clinical Quality Functional Area review to ensure the review meets its intended purpose and remains current with external and internal requirements, including seamless integration with Clinical Operations and CVIA Leadership Team Management review.
- Assess gaps, develop, and implement robust quality management systems for clinical practices, ensuring adherence to regulatory standards and best practices.
- Provide leadership and oversight for training programs related to clinical quality assurance. Ensure that employees and relevant stakeholders receive appropriate training on quality standards, regulations, and procedures.
- Relentlessly explore leading edge, innovative principles and practices associated with progressive quality management; takes bold steps to incorporate into Company Quality strategy, Quality Management systems, practices; continuously drive meaningful change.
- Drive recommendations and manage tasks to closure, providing guidance and support to resolve issues identified during audits and inspections.
- Provide interpretation and guidance on GCP related regulations/ guidelines (FDA, ICH, EU, etc.), including Risk Based Quality Management, and company procedures and policies.
- Collaborate with PATH partners, including Principal Investigator (PI) and Contract Research Organizations (CROs), to ensure alignment on quality expectations and timely resolution of issues.
- Coordinate with cross-functional teams (e.g., Program Leads, Clinical Operations, Biostatistics, Data Management, Pharmacovigilance) to develop and implement phase-appropriate procedures ensuring consistency and quality with respect to clinical trial support activities.
- Manage international inspections, ensure readiness and compliance of clinical sites, and provide feedback and recommendations for improvement.
- Report GCP related deficiencies and associated risks to management as well as plans for risk mitigation and corrective and/or preventive actions (CAPA).
- Develop strategy, lead and conduct risk-based international audits of clinical sites, liaising with FDA, WHO, and local inspection groups to ensure compliance and mitigate risks to ongoing studies.
- Provide guidance and support to cross-functional teams, driving alignment and implementation of quality assurance plans.
- Drive initiatives and ensure timely completion of deliverables.
Required skills and experience
- Bachelor's degree in a relevant field; advanced degree preferred.
- At least 15 years of progressive experience in quality clinical roles, with a focus on international clinical studies.
- At least 12 years of experience in mapping and overseeing a Clinical Quality program that supports clinical studies in Low- and Middle-Income Countries (LMICs).
- At least 12 years of experience with the application of FDA and/or OECD GLPs to studies conducted to support the approval or registration of vaccine product.
- At least 10 years of experience as a GLP/GCLP auditor for laboratory studies or field trials. Certification as a Certified Quality Auditor (CQA) highly desired.
- Previous experience working in at minimum 2-3 GCP organizations with exposure to different QMS models and regulatory environments.
- A track record of building high-functioning Clinical Quality programs while advising key stakeholders, as well as extensive experience in GCP auditing and/or managing regulatory authority inspections is required.
- Proven ability to manage international inspections and audits, with a track record of successful outcomes.
- Broad and deep global health regulatory agency knowledge and experience across multiple GxPs with particular expertise in GCP/GLP regulations and their execution/application across the vaccine product lifecycle.
- Demonstrated ability to drive results, including taking accountability and ownership to drive staff accountability through empowerment, driving with urgency, expertise, and judgment, and effective time management skills.
- Proficient in project management methodologies, with project management certification preferred.
- Ability to utilize creative thinking processes and tools to arrive at simplified solutions for complex problems.
- Excellent interpersonal skills with an ability to effectively work and problem solve within a multidisciplinary team.
- Demonstrated cultural sensitivity and proficiency in conflict resolution to effectively navigate diverse international environments.
- Ability to work independently with minimal supervision, while effectively multitasking and prioritizing competing demands.
- Ability and willingness to travel internationally as needed, approximately 30%.
- Must have legal authorization to work in the US, UK, Switzerland, or Belgium. Fully remote candidates in these locations will be considered.
PATH is a diverse nonprofit organization that creates a culture of collaboration and partnership. Learn more about the impact you can make globally here.
We offer our employees a competitive salary and generous benefits. For candidates based in the U.S., the annual salary range for this position is $200,000-$250,000. The final salary is based on a variety of objective factors.
PATH provides a comprehensive benefit package that includes 15 vacation, 11 holiday, 2 personal and 12 sick days per year; medical and dental plans; life insurance; disability and retirement benefits.
Hybrid Work
PATH operates within a hybrid workplace model unless otherwise noted. Hybrid employees must reside within commuting distance to one of our PATH offices. PATH's US offices are located in Seattle, WA and Washington, DC. Fully remote candidates will be considered.
PATH is dedicated to building an inclusive workforce where diversity is valued.
PATH is an equal opportunity employer. Every qualified applicant will be considered for employment.
PATH does not discriminate based on race, color, religion, caste, gender, sexual orientation, gender identity, genetic information, age, national origin, marital status, disability status, political ideology, military or protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
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